Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02

Condition(s) targeted: Breast Cancer; Osteoporosis

Intervention: laboratory biomarker analysis (Other); dual x-ray absorptiometry (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: International Breast Cancer Study Group

Official(s) and/or principal investigator(s):
Olivia Pagani, MD, Study Chair, Affiliation: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future.

PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).

Official title: TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase

Serial serum levels of IGF-1 and IGFBP-3

Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)

Detailed description: OBJECTIVES:

- Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in

protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years.

- Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin,

bone-specific alkaline phosphatase) and investigate their correlation with BMD.

- Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD.

- Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their

time course correlates with BMD.

- Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome

(disease-free survival). (exploratory)

OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum markers of bone remodeling and serum growth factor levels are measured.

Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of the hip is measured by DEXA at baseline and then periodically for 6 years.

Any surplus serum is stored for use in unspecified future research.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

DISEASE CHARACTERISTICS:

- Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in

TEXT-Bone

- Serial bone marrow density (BMD) measurements must be taken within the same

institution

- Hormone receptor positive

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- Premenopausal

- No bone fracture in the past 6 months that, in the investigator's judgement, could be

related to bone fragility

- No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active

hyper- or hypoparathyroidism, or Paget's disease

- No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases

- No other bone disease (including osteomalacia or osteogenesis imperfecta)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone

therapies such as PTH or strontium)

- At least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for >

1 month

- At least 12 months since prior anticonvulsants

Oncology Institute of Southern Switzerland, Bellinzona CH-6500, Switzerland; Recruiting
Olivia Pagani, MD, Phone: 41-91-820-9111, Email: olivia.pagani@ibcsg.org

Tom Baker Cancer Centre - Calgary, Calgary, Alberta T2N 4N2, Canada; Recruiting
Barbara A. Walley, MD, FRCPC, Phone: 403-521-3688, Email: bwalley@cancerboard.ab.ca

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2009
Last updated: July 26, 2012